The European Commission (EC) has decided that the existing EU medical device directive (MDD) is not rigorous enough and it has been recast to the medical device regulation (MDR).
The difference between a directive and a regulation is that all member states in the EU are legally bound to abide by a regulation without any modifications (it enters law immediately), and the EC can take measures to punish countries, manufacturers, importers, distributors or even individuals if it feels that any transgressions have been made and the local authorities have not been zealous enough in ensuring compliance. The wording used in a regulation is necessarily dictatorial.
The following checklist from RECOM may help manufacturers wanting to stay in the medical market after 2024:
1. If you are an importer or distributor, you will have the same responsibilities and liabilities as if you were a manufacturer. Unless you have direct contact with the original manufacturer with access to the design team, supply chain management and production, you will struggle to meet the regulatory requirements for traceability and post-market surveillance.
2. As a manufacturer of a component that in itself is not a medical device (for instance, a power supply), you will not be required to carry out clinical trials or apply for a unique identification code. However, you will still need to support and react to any adverse results arising from the use of the product inside the medical device over its lifetime. It is advisable to create a serial number for every product supplied, linked to full documentation (production testing results, quality control, bill of materials). A simple date code identifier will probably be insufficient.
3. If the supplied part has a potential hazard (electrical, thermal, sharp-edges or radiation), you will be required to carry out a risk assessment. This goes beyond the simple safety or EMC certifications, but will need to be an ongoing and regular re-assessment. You will need to contact each and every customer who has purchased the product on a regular basis over the lifetime of the product. It would be advisable to enter into a contractual arrangement with customers to formalise this procedure.
4. There are not enough notified bodies (NBs) accredited to meet the requirements for the MDR. It can be that a new medical product may have a delayed market entry because there is no NB available to take on the responsibility of monitoring it. Plan also for increased costs as demand outstrips supply.
5. Manufacturers will be required to have someone within the organisation responsible for regulatory compliance who possesses expert knowledge in the field of medical devices. If there is no such specialist in-house, you will need to make arrangements with an external consultant.
The MDR will apply to all medical device manufacturers, meaning every manufacturer of a medical device or accessory will have new obligations. The MDR is perhaps unique in defining job descriptions of staff that must be employed by manufacturers if they wish to stay in the medical market and by giving the notified bodies extra duties to act as policing organisations, rather than just industry certification partners.
